We want to share the acknowledgment that APICES has received in BLARWE study, which is a bladder cancer retrospective study, published in the ASCO GU 2025 congress, in which APICES has collaborated in start-up, project management, monitoring, biostatistics, and medical writing activities.
This means a great motivation to all the APICES team to give continuity to the implication we have in every project in which we collaborate. APICES is very proud of the recognition of our work, and we would like to thank AstraZeneca, and Dr. Javier Puente for giving us the opportunity to appear in the acknowledgments of the publication and congratulate them and all the investigators for their project success.
This retrospective study aims to provide a comprehensive description of the epidemiology of bladder cancer in Spain, and to generate robust evidence on the clinical characteristics, treatment patterns, and clinical outcomes of these patients in routine clinical practice.
You can find further information in the following link: Real-world epidemiology and clinical outcomes of bladder cancer patients in Spain: BLARWE multicenter study. | Journal of Clinical Oncology
Get the latest clinical insights delivered to your feed or inbox!
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.
